• 제목/요약/키워드: Trial

검색결과 7,875건 처리시간 0.031초

Effect of a Copper, Selenium and Cobalt Soluble Glass Bolus Given to Grazing Yaks

  • Liu, Zongping
    • Asian-Australasian Journal of Animal Sciences
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    • 제20권9호
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    • pp.1433-1437
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    • 2007
  • Two field trials were carried out to evaluate the performance of a soluble glass copper, cobalt and selenium bolus for maintaining adequate levels of the three trace elements in yaks. Forty yaks were used in trial 1 and 60 yaks were used in trial 2. In each trial two commercial soluble glass boluses were administered to half of the yaks. Blood samples were taken from the jugular vein at day 0, 30, 60, 90 in trial 1 and at day 0, 45, 75 and 105 in trial 2. The samples were analysed for copper status (serum caeruloplasmin activity and copper concentration), cobalt status (serum vitamin $B_{12}$ concentration and cobalt concentration), selenium status (erythrocyte glutathione peroxidase activity and selenium concentration) and serum zinc concentration. The erythrocyte glutathione peroxidase activities, serum caeruloplasmin activities and serum vitamin $B_{12}$ concentrations for trial 1 and 2 were all significantly increased for the bolused yaks (p<0.001 or p<0.01) on all sampling days. The bolused yaks had a significantly higher selenium and copper status in serum than the control yaks on all sampling days in trial 1 and 2 (p<0.05 or p<0.01). There were no significant differences in zinc and cobalt concentrations between the bolused yaks and the controls.

Analysis of Failed Spinal Cord Stimulation Trials in the Treatment of Intractable Chronic Pain

  • Jang, Hyun-Dong;Kim, Min-Su;Chang, Chul-Hoon;Kim, Sang-Woo;Kim, Oh-Lyong;Kim, Seong-Ho
    • Journal of Korean Neurosurgical Society
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    • 제43권2호
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    • pp.85-89
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    • 2008
  • Objective: The purpose of this study is to identify the factors affecting the failure of trials (<50% pain reduction in pain for trial period) to improve success rate of spinal cord stimulation (SCS) trial. Methods: A retrospective review of the failed trials (44 patients, 36.1 %) among the patients (n=122) who underwent SCS trial between January 1990 and December 1998 was conducted. We reviewed the causes of failed trial stimulation, age, sex, etiology of pain, type of electrode, and third party support. Results: Of the 44 patients, 65.9% showed unacceptable pain relief in spite of sufficient paresthesia on the pain area with trial stimulation. Four of six patients felt insufficient paresthesia with stimulation had the lesions of the spinal cord. Seventy five percent of the patients experienced unpleasant or painful sensation during stimulation had allodynia dominant pain. Third-party involvement, sex, age and electrode type had no influence on the outcome. Conclusion: We conclude that SCS trial is less effective for patients with neuropathic pain of cord lesions, postherpetic neuropathy or post-amputation state. Further, patients with allodynia dominant pain can feel unpleasant or painful during trial stimulation.

갱년기 여성의 안면홍조에 대한 이선탕가미방(二仙湯加味方)의 증상완화 효과 및 안전성 평가를 위한 임상연구 (Clinical Trial to Evaluate the Hot Flush Relief Efficacy and Safety of Yiseontang-gami in Climacteric Women with Hot Flushes)

  • 정수경;김동일
    • 대한한방부인과학회지
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    • 제21권3호
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    • pp.75-89
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    • 2008
  • Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS. Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

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A PRIME FACTORIZATION ALGORITHM, IN ACTIONSCRIPT

  • Song, Tai-Sung
    • East Asian mathematical journal
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    • 제19권1호
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    • pp.81-89
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    • 2003
  • There are many algorithms for factoring integers. The trial division algorithm is one of the most efficient algorithms for factoring small integers(say less than 10,000,000,000). For a number n to be factored, the runtime of the trial division algorithm depends mainly on the size of a nontrivial factor of n. In this paper, we create a function named factors that can implement the trial division algorithm in ActionScript and using the factors function we construct an interactive Prime Factorization Movie and an interactive GCD Movie.

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의약품 임상시험에서 피험자 보호 (A Study on the Protection of Trial Subjects in Clinical Trials of Investigational New Drug)

  • 위계찬
    • 의료법학
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    • 제13권2호
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    • pp.79-113
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    • 2012
  • This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

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말기 암 환자에 대한 임상시험과 피험자의 자기결정권의 본질 (The Clinical Trial of Terminal Cancer Patients and The Nature of Self-Determination of The Subject)

  • 송영민
    • 의료법학
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    • 제15권1호
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    • pp.211-237
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    • 2014
  • Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

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원주지역 여고생의 체중감량 시도 여부에 따른 체중조절 태도, 영양지식 및 식행동에 관한 연구 (A Study on Weight Control Attitude, Nutrition Knowledge and Dietary Behavior by Weight Control Attempt of High School Female Students in Wonju Area)

  • 이경원;김복란
    • 한국가정과교육학회지
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    • 제20권4호
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    • pp.91-105
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    • 2008
  • 본 연구는 원주지역 여자고등학생 503명을 대상으로 설문지를 이용하여 체중감량 시도 여부에 따라 체중조절 태도, 체중조절과 관련된 생활습관, 영양지식, 식행동에 대한 차이를 알아보았다. 조사대상자 중 체중감량을 시도한 여고생은 284명(58.4%)이었으며, 체중감량 시도군의 94.7%, 비시도군의 60.7%는 체중조절에 대한 관심이 높았다. 체중감량 시도군의 85.2%와 비시도군의 50.3%는 자신의 체형에 불만인 것으로 나타났다. 체중감량 시도군의 21.8%는 규칙적으로 운동을 하여 비시도군(5.5%)의 운동자 비율보다 높은 비율을 보였다. 대상자의 영양지식점수는 평균 14.3점(20점 만점)으로 체중감량 시도군(14.5점)은 비시도군(13.9점)에 비해 유의하게 점수가 높게 나타났으며(p<0.01), 특히 균형식, 체중조절 관련 지식 등의 항목에서 정답률이 높았다. 식행동은 평균 31.3점(가능점수: $15{\sim}445$점)으로 보통인 편이었고, 특히 식사속도, 다양한 음식섭취, 식품군별 섭취빈도(유제품, 해조류, 식물성 유지)에서 문제가 나타났으며, 체중감량 시도군은 비시도군에 비해 식물성 기름을 사용한 음식을 먹는 비율이 높게 나타났다. 본 연구결과 여고생들에게 체형에 대한 올바른 인식과 체형에 대한 만족도를 높여주는 영양교육을 해야 할 것이며, 이들에게 올바른 체중조절을 위한 방법과 바람직한 식생활 행동을 할 수 있는 교육이 이루어져야 할 것이다.

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The Effect of Varying Levels of Tryptophan on Growth Performance and Carcass Characteristics of Growing and Finishing Broilers

  • Hsia, L.C.;Hsu, J.H.;Liao, C.T.
    • Asian-Australasian Journal of Animal Sciences
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    • 제18권2호
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    • pp.230-234
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    • 2005
  • The purpose of this experiment was to study the effect of varying levels of tryptophan on the performance and carcass character of broiler. Trial 1: Ninety-six, five-week-old male Hubbard chickens, average weight 1.97 kg, were used in the trial. All birds were allocated into 3 treatments of 32 birds each. Each bird was kept in an individual cage. The trial period was 3 weeks. Treatment 1: Tryptophan content 0.198%. Treatment 2: Tryptophan content 0.228%. Treatment 3: Tryptophan content 0.258%. Trial 2: Ninety-six, three-week-old male Hubbard chickens, average weight 1.23 kg, were randomly distributed into the following two treatments. Each treatment had 48 birds. Treatment 1: Tryptophan content 0.167%. Treatment 2: Tryptophan content 0.198%. Trial 3: Ninety-six, twoweek-old Hubbard chickens, average body weight 0.72 kg, were used in this experiment. There were three treatments as follows. Treatment 1. Tryptophan content 0.136%. Treatment 2. Tryptophan content 0.167%. Treatment 3. Tryptophan content 0.198%. The result of Trial 1 showed that the feed intake, performance, and carcass characteristics were not influenced by tryptophan content in the diet which between 0.198% and 0.258% (p>0.05). There was no significant difference (p>0.05) in feed intake in either treatment in Trial 2. However, weight gain, feed conversion efficiency, and most carcass characteristics in the 0.198% treatment were significantly better (p<0.05) than in the 0.167% treatment. There was a trend that feed intake increased with increasing level of tryptophan, but there was no significant difference in Trial 3. The weight gain and feed conversion efficiency were significantly reduced for the broiler in the 0.136% treatment. This series of experiment showed that broilers need about 0.198% of tryptophan.

An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

  • Park, Soo-Hyun;Oh, Mi-Ra;Choi, Eun-Kyung;Kim, Min-Gul;Ha, Ki-Chan;Lee, Seung-Kwon;Kim, Young-Gon;Park, Byung-Hyun;Kim, Dal-Sik;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • 제38권4호
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    • pp.239-243
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    • 2014
  • Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

위암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer])

  • 한가진;성신;김성수;김진성;박재우
    • 대한한의학회지
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    • 제38권3호
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    • pp.124-142
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    • 2017
  • Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].